# K972783: Biofix Biodegradable Threaded Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Inc.
- Decided: Apr 14, 1998 after 263 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904436 (1990). 8 ancestors in all.
166 later devices descend from it; 3 cite it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950875: Ogden Anchor, American Medical Electronics, Inc. (1995) Summary page 1.
- K962397: Statak Soft Tissue Attachment Device, Zimmer, Inc. (1996) Summary page 1.
- K960516: Fastak Suture Anchor, Arthrex, Inc. (1996) Summary page 1.
- K953877: Mitek Gii Anchor, Mitek Surgical Products, Inc. (1995) Summary page 1.
- K961555: Acufex Tag Bioabsorbable Anchors, Acufex Microsurgical, Inc. (1996) Summary page 1.

## Most influential descendants
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System (1998), 86 descendants of its own
- K993061: Stryker Leibinger Resorbable Fixation System (1999), 79 descendants of its own
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own

## Indications for use
The Bionx Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach ligaments to the shoulder bone, i.e., for rotator cuff or Bankart lesion repair. The device may be attached to either the articular facet surface or to a metaphyseal region of the bone, provided that the thickness of the cortex is less than 1.5 mm.

Source page: https://510kreport.com/device/K972783
Methodology: https://510kreport.com/methodology